Access to Hormonal Contraception: Is It Time We Considered Over-the-Counter Status?

Snewsome

Regardless of how split Americans are with regard to the abortion debate, we should all be able to agree on the need to prevent pregnancies. However, an obvious approach to pregnancy prevention is being sidelined by the lack of over-the-counter availability of hormonal contraceptives.

Regardless of how split Americans are with regard to the abortion debate, we should all be able to agree on the need to prevent pregnancies. However, an obvious approach to pregnancy prevention is being sidelined by the lack of over-the-counter availability of hormonal contraceptives.

Sadly, the US has one of the world’s highest of rates of unintended pregnancies, particularly among teenage girls.[1]  About half of all pregnancies are unintended, and in spite of Oklahoma and other states’ incremental policies to restrict abortion, 42 percent of those unintended pregnancies are voluntarily terminated.[2] While public policy discussions tend to focus on the hot-button issue of abortion, one approach that could substantially reduce the number of unplanned pregnancies is undermined by unnecessary roadblocks from the Federal government—as well as health care providers—and therefore has not been given a sufficient chance. Hormonal contraception, such as the birth-control pill (BCP), vaginal rings, and patches, should be available without a prescription.

Hormonal contraception meets the Federal Food & Drug Administration (FDA) standards for non-prescription status; consumers can easily identify contraindications, directions for use are uncomplicated, the benefits outweigh risks, and health providers are not necessarily required. Not only is hormonal contraception not available without a prescription, many clinicians force unnecessary medical examinations before allowing women access. In addition, the “conscience regulation” enacted by George W. Bush and not yet overturned by President Obama, allows health care providers to withhold prescriptions and even give patients inaccurate medical information, if they so choose.

Though we often hear of a possible association between BCPs and strokes or heart attacks, those risks are much lower than the risk of suffering liver damage from over-the-counter acetaminophen. Aspirin and ibuprofen have even more safety risks, such as ulcers, bleeding, high blood pressure, and kidney disease.[3]  Hormonal contraception has been proven safe—pregnancy is seven times more dangerous than pills, smoking is 50 times more dangerous than pills, driving is 12 times more dangerous than pills[4]—according to numerous respected medical organizations, including the World Health Organization, the American College of Obstetricians and Gynecologists, the Royal College of Obstetricians and Gynecologists, and the American Medical Association.

Like This Story?

Your $10 tax-deductible contribution helps support our research, reporting, and analysis.

Donate Now

In a 2000 article, Emery University’s Robert Hatcher, professor of Gynecology and Obstetrics, stated that the BCP’s history has shown it to be perfectly safe for use over-the-counter. Arie Yeshaya, M.D. of the Department of Obstetrics and Gynecology, confirmed that severe complications are rare (venous thrombosis occurs in 6 out of 10,000 women using oral contraception, as opposed to 3 out of 10,000 non-oral contraception users). Daniel Grossman, Senior Associate at Ibis Reproductive Health, cites a 2004 US national survey of women that reported 41 percent of women not using contraception said they would begin using the pill, patch, or vaginal ring if it were available without a prescription in a pharmacy. Another similar study found that travel away from home and running out of pill packs were common reasons women missed pills—a frequent cause of contraceptive failure.[5]

Why then, is the US still illogically holding birth control captive? In reality, the reason behind these pointless policies may not be health considerations, but rather moral objections on the part of the FDA, which contends that it is the pharmaceutical industry’s responsibility to seek approval for over-the-counter marketing of drugs. However, in 2000, the agency held a hearing to consider making BCPs available on a non-prescription basis and then ruled against it. It did the same with Plan B, also known as the morning after pill, prompting the 2005 resignation of Susan Wood, former Assistant Commissioner for Women’s Health. Wood was protesting the insertion of abortion-era politics into what should be a strictly health issue.

Not only are women in the United States required to make costly and time-consuming visits to a doctor’s office to get birth-control pill prescriptions, they are often required to undergo unnecessary and perhaps unwanted physical examinations and tests. The World Health Organization, Planned Parenthood Federation of America, and the American College of Obstetricians and Gynecologists,[6] and the American Medical Association, do not consider breast or pelvic examinations necessary for distribution of birth control pills. Incredibly, Sarah Jarvis, women’s health spokesperson of Royal College of General Practitioners in London, when arguing against allowing hormonal contraception available without a prescription, even stated that the pill is safe.[7]  

Why might women not want to meet with doctors? There are several possibilities. Given the state of our current economy, many women are already struggling financially and medical procedures compound expenses. For others, time is an issue. Some women find themselves in need of a prescription refill and unable to visit a clinic or get an appointment with a doctor in time. For some women, the intrusiveness of the exams and test is enough to prevent them from seeking them. Yet another reason, as exemplified by the recent change in pap smear recommendations, is that some women simply think the exams are unnecessary.  Until recently the standard recommendation, which many doctors and university clinics required, was an annual pap smear on record. This has recently been changed to every two years (every three for women over thirty).

Another concern asserted by Michael Cackovic, MD and Michael J. Paidas, MD[8] is that women will stop going for annual exams and pap tests if health centers don’t have a paternalistic policy of withholding contraception. According to this logic, no one should be allowed any medications unless they have all recommended physical exams. Over 55 and haven’t had a colonoscopy? Sorry, no flu shot for you. Misleading women is a form of coercion, not informed consent. Respect for the individual and their ability to make decisions is a basic principle of medical ethics. Not doing so is nothing short of provider bias and paternalism. Would women miss out on other preventive services, such as cervical smear tests or breast exams, if they were not required to visit a clinician? How many men actually go for their annual prostrate exam? Let’s allow women, like all mentally competent adults, to make their own decisions regarding their bodies. Shouldn’t patients, including women of child-bearing age, have the right to autonomy and bodily integrity? This logic could also be used to withhold long-lasting birth control such and IUD’s and sterilization. Not a good idea given the number of unintended pregnancies in the US.

Another hypothesis voiced by health professionals is that women might not understand how to take their contraception, however several international studies have found that over-the-counter provision of oral contraceptives by pharmacists is a safe, effective, and practical. Additionally, two US studies found that women were able to identify if oral contraceptives would not be a good choice for them.[9]

Already in Washington State, there is an initiative to de-medicalize hormonal contraception, thus making it readily available to women. Pharmacy Access Partnership, a center within the Pacific Institute for Women’s Health, is working with advocates, researchers, and providers to make hormonal contraception over-the-counter. Thus far, they’ve found it to be a practical idea and currently, one in five states has regulations that would permit pharmacists to provide pharmacy access to HC.

one stands on the abortion debate, most Americans would agree that it should not be a form of birth control and most wish to see it rarely used as a last resort. The prevention of pregnancy is a choice that women should be entitled to make for themselves. As consumers, we have the power to help to decrease unwanted pregnancies and access to hormonal contraception in pharmacies can be within our reach. Let’s encourage efforts to decrease abortion and increase women’s bodily autonomy by freeing contraception from the ties that bind it.

[1] Singh, S. and Darroch, J.E., “Adolescent pregnancy and childbearing: levels and trends in developed countries.” Family Planning Perspectives, 2000, 32(1): pg 14–23. http://www.guttmacher.org/pubs/journals/3201400.html

[2] Finer, L.B. and Henshaw, S.K., “Disparities in rates of unintended pregnancy in the United States.” Perspectives on Sexual and Reproductive Health, 2006, 38(2): pg 90–96. http://www.guttmacher.org/pubs/fb_induced_abortion.html

[3] Childs, Dan. “FDA Scrutinizes Acetaminophen’s Liver Risk Concerns Over Unintentional Overdose Hazards May Change Drug’s Labeling,” June 29, 2009. http://abcnews.go.com/Health/PainManagement/story?id=7955370&page=1

[4] CNN.com “No prescription for the pill? FDA considers making the pill available over-the-counter.” June 29, 2009. http://archives.cnn.com/2000/HEALTH/women/06/29/pill.prescriptionns/index.html

[5] BMJ 2008;337:a3044 http://www.bmj.com/cgi/content/extract/337/dec23_2/a3044

[6] Leeman, L. “Medical barriers to effective contraception.” Obstet Gynecol Clin North Am. 2007; 34: pg 19–29.

[7] BMJ 2008;337:a3056 http://www.ncbi.nlm.nih.gov/pubmed/17472862

[8] Daniel Grossman, MD; Michael Cackovic, MD; and Michael J. Paidas, MD. “Viewpoints: Should oral contraceptives be sold over-the-counter?” Contemporary GYN/OB, September 1, 2008. http://contemporaryobgyn.modernmedicine.com/obgyn/author/authorInfo.jsp?id=36190

[9] BMJ 2008;337:a3044 http://www.bmj.com/cgi/content/extract/337/dec23_2/a3044

News Abortion

FDA’s Update to Medication Abortion Regulations a Boon for Access

Teddy Wilson

There have been dozens of bills introduced in the past few years to restrict medication abortion access. This year lawmakers have introduced similar bills in Iowa and New Hampshire.

The U.S. Food and Drug Administration (FDA) approved a label change Wednesday for mifepristone, a drug known as RU-486 used during medication abortions. The change brings federal regulations in line with scientific research and evidence-based medicine.

Anti-choice legislators have for years restricted access to medication abortion by charging that off-label use of abortion-inducing medication posed a danger to pregnant people.

When the FDA approved medication abortion for use in the United States in 2000, the agency adopted the regimen that had been developed by French researchers in 1988. However, medical consensus is that this protocol is outdated.

The FDA updated the agency’s supplemental application for Mifeprex, the brand name of the drug distributed by Danco Laboratories, based on data and information submitted by the drug manufacturer. After reviewing the supplemental application, the agency determined that Mifeprex is safe and effective when used to terminate a pregnancy in accordance with the revised labeling.

Like This Story?

Your $10 tax-deductible contribution helps support our research, reporting, and analysis.

Donate Now

The FDA label change announced Wednesday will increase the time a pregnant person has to receive a medication abortion, from 49 days to 70 days of gestation.

Vicki Saporta, president and CEO of the National Abortion Federation (NAF), said in a statement that since mifepristone was initially approved by the FDA in 2000, NAF members have used an evidence-based regimen that has allowed for a lower dose of mifepristone.

“Because providers in the United States have already been providing evidence-based care, which the new label now recognizes, actual practice will not change,” Saporta said. “What will change is that politicians can no longer deny women access to this safe and effective method of early abortion care by insisting on an out-dated regimen.”

A medication abortion is a non-surgical procedure by which pregnancy is terminated through the use of two drugs. The first drug, mifepristone, works by blocking the hormone progesterone, which causes the lining of the uterus to break down so that the pregnancy cannot continue. The second drug, misoprostol, which causes cramps and heavy bleeding that usually lasts for a few hours, induces contractions and ends the pregnancy.

Anti-choice lawmakers in recent years have targeted medication abortion with legislation designed to restrict access to abortion care. Republican state lawmakers have been aided by anti-choice organizations such as Americans United for Life, which has drafted copycat bills designed to make medication abortion inaccessible.

These anti-choice bills force doctors to administer medication abortion in a manner that contravenes research-driven guidelines published by the most trusted public health organizations, including the World Health Organization, the American College of Obstetricians and Gynecologists, and the American Medical Association.

A five-year study of 13,000 women published last year in the journal Contraception found that evidence-based alternatives to the FDA-approved regimen for medication abortion are safe and effective. The study found that the evidence-based protocols were more than 98 percent effective for pregnancies of up to 42 days’ gestation, and more than 95 percent effective up to 63 days.

There have been dozens of bills introduced in the past few years to restrict medication abortion. This year lawmakers have introduced similar bills in Iowa and New Hampshire.

Lawmakers in Ohio and Texas passed laws that required mifepristone be provided in accordance with the outdated FDA protocol. North Dakota and Oklahoma have enacted laws requiring the use of the FDA protocol, but those GOP-backed laws have been blocked by courts and are not in effect.

An Arizona state court judge last year permanently blocked a state law that mandated physicians to follow the outdated protocol established by the FDA when administering “any medication, drug, or substance” to induce an abortion.

Last week Arizona’s Republican-majority house once again approved a bill requiring doctors to follow the same outdated standards on medication abortion.

“We hope the new label changes will soon allow women to access medical abortion care in states where anti-choice restrictions have made this evidence-based care unavailable,” Saporta said.

Dr. Nancy Stanwood, board chair of Physicians for Reproductive Health, praised the FDA for approval of the label change.

“We applaud the FDA for recognizing the safety of medication abortion and the voluminous research that shows evidence-based regimens are beneficial to patients,” Stanwood said in a statement. “As physicians, we work every day to provide the highest quality care to our patients. An updated label means that providers in states that require adherence to the FDA-approved Mifeprex label will not have to practice outdated medicine.”

Roundups Sexual Health

This Week in Sex: News From the HIV Epidemic

Martha Kempner

This week in sex: Scientists report the first case of HIV transmission to a patient adhering to PrEP protocols, two studies show a new vaginal ring can help women prevent HIV, and young people still aren't getting tested for the virus.

This Week in Sex is a weekly summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

With the death of Nancy Reagan, the 1980s AIDS crisis is back in the national spotlight. But, of course, HIV and AIDS are still ongoing problems that affect millions of people. This week in sex, we review scientists reporting the first case of HIV transmission to a patient adhering to PrEP protocols, two studies showing a new vaginal ring can help women prevent HIV, and evidence that young people still aren’t getting tested for the virus.

First Case of HIV Transmission While on Truvada

Last week, Canadian scientists reported on what they believe to be the first HIV infection in a patient who was following a PreP (Pre-Exposure Prophylaxis) regimen.

Like This Story?

Your $10 tax-deductible contribution helps support our research, reporting, and analysis.

Donate Now

PrEP is a method of HIV prevention. By taking a daily pill that contains two HIV medicines, sold under the name Truvada, individuals who are HIV-negative but considered to be at high risk of contracting the virus can prevent infection. Studies have found that PrEP is very effective—the Centers for Disease Control and Prevention estimates that people who take the medication every day can reduce their risk of infection by more than 90 percent from sex and by more than 70 percent from injection drug use. One study of men taking PrEP found no infections over a two-and-a-half-year period.

PrEP is less effective when not taken regularly, but the new case of reported PrEP failure involves a 43-year-old man who said that he took his medication daily. His pharmacy records back up that assertion. The man’s partner has HIV, but is on a drug regimen and has an undetectable viral load. The man did report other sexual encounters without condoms with casual partners in the weeks leading up to his diagnosis.

Dr. David Knox, the lead author of this case study, notes that it is difficult to know if a patient really did adhere to the drug regimen, but the evidence in this case suggests that he did. He concluded, “Failure of PrEP in this case was likely due to the transmission of a PrEP-resistant, multi-class resistant strain of HIV 1.”

Experts say, however, that they never expected PrEP to be infallible. As Richard Harrigan of the British Columbia Center for Excellence in HIV/AIDS told Pink News, “I certainly don’t think that this is a situation which calls for panic …. It is an example that demonstrates that PrEP can sometimes be ineffective in the face of drug resistant virus, in the same way that treatment itself can sometimes be ineffective in the face of drug resistant virus.”

Still, some fear that the new study will add to the ongoing debate and apathy that seem to surround PrEP. While some experts see it as a must-have prevention tool, others worry that it will encourage men who have sex with men to forgo using condoms and perhaps increase their risk for other sexually transmitted infections. Still, only 30,000 people in the United States are taking the drug—an estimated one-twentieth of those who could benefit from it.

A New Vaginal Ring Could Help Women Prevent HIV Infection

Researchers have announced promising results from two studies looking at new technology that could help women prevent HIV. The dapivirine ring, named after the drug it contains, was developed by the International Partnership for Microbicides. It looks like the contraceptive ring, Nuvaring, and is similarly inserted high up into the vagina for a month at a time. Instead of releasing hormones to prevent ovulation, however, this ring releases an antiretroviral drug to prevent HIV from reproducing in healthy cells. (A ring that could prevent both pregnancy and HIV is being developed.)

The two studies of the ring are being conducted in Africa. One study recruited about 2,600 women in Malawi, South Africa, Uganda, and Zimbabwe. It found that the ring reduced HIV infection by 27 percent overall and 61 percent for women over age 25. The other study, which is still underway, involves just under 2,000 women in seven sites in South Africa and Uganda. Early results suggest that the ring reduced infection by 31 percent overall when compared to the placebo.

Both studies found that the ring provided little protection to women ages 18-to-21. Researchers are now working to determine how adherence and other biological factors may have impacted such an outcome.

Young People Not Getting Tested for HIV

A study in the February issue of Pediatrics found that HIV testing rates among young people have not increased in the last decade. The researchers looked at data from the Youth Risk Behavior Survey (YRBS), which asks current high school students about sexual behaviors in addition to questions about drugs and alcohol, violence, nutrition, and personal safety (such as using bike helmets and seat belts). Specifically, the YRBS asks students if they’ve ever been tested for HIV.

Using YRBS data collected between 2005 and 2013, the researchers estimated that 22 percent of teens who had ever had sex had been tested for HIV. The percent who had received HIV tests was higher (34 percent) among those who reported four or more lifetime partners. Overall, male teens (17 percent) were less likely than their female peers (27 percent) to have been tested.

Researchers also looked at data from the Behavioral Risk Factor Surveillance System, which asks similar questions to young adults ages 18 to 24. Among people in this age group, between the years of 2011 to 2013, an average of 33 percent had ever been tested. This review of data also found that the percentage of young women who get tested for HIV has been decreasing in recent years—from 42.4 percent in 2011 to 39.5 percent in 2013.

The authors simply conclude, “HIV testing programs do not appear to be successfully reaching high school students and young adults.” They go on to suggest, “Multipronged testing strategies, including provider education, system-level interventions in clinical settings, adolescent-friendly testing services, and sexual health education will likely be needed to increase testing and reduce the percentage of adolescents and young adults living with HIV infection.”